The Effects of Glycine on Atherosclerosis and Metabolic Syndrome-related Parameters.

Last updated: February 20, 2019
Sponsor: Prof. Tony hayek MD
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Obesity

Metabolic Syndrome

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT03850314
RMB-18-0621
  • Ages 40-65
  • Male

Study Summary

The current study will test the central hypothesis that Glycine supplementation in humans improves Lipid profile and therefore reduces the risk of Atherosclerosis. Secondary outcomes including Insulin sensitivity and parameters related to Metabolic Syndrome (MetS) will also be measured. Furthermore, a mechanistic study in an ex-vivo model will test the hypothesis that Glycine via its key biosynthetic pathway involving Serine Hydroxymethyltransferase 2 (SHMT2), is athero-protective by inhibiting Sterol regulatory element-binding protein 2 (SREBP2)-mediated cholesterol biosynthesis in murine macrophage-like cell line.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male between the ages of 40-65 years old.

  • Fulfill at least three of the five diagnostic criteria for the Metabolic Syndrome.

  • To be able to give their written consent to participate in this study.

Exclusion

Exclusion Criteria:

  • Abnormal Liver function tests ≥ 3 times upper limit of normal (ULN).

  • Chronic liver disease other than NAFLD.

  • Previous gastric or small bowel surgery.

  • Abnormal Thyroid-stimulating hormone (TSH) level.

  • Known Tobacco Smoking more than 10 cigarettes per day.

  • Known alcohol consumption more than 2 drink per day.

  • Use of medications that include: Insulin or Insulin secretagogues, Thiazolidinediones,Glucocorticosteroids, Hormone replacement therapy.

  • Fever > 38.2 °C in the past 2 weeks.

  • Autoimmune or Auto-inflammatory disease.

  • Chronic kidney disease ≥ stage III.

  • Nephrotic syndrome.

  • Hemoglobin <12 g/dL.

  • Metal clips or implants that preclude magnetic resonance imaging.

Study Design

Total Participants: 50
Study Start date:
March 01, 2019
Estimated Completion Date:
June 30, 2020